BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX WAVESCAN WAVEFRONT SYSTEM

    MDR report key: 1241804 · Received November 21, 2008

    Report

    Report Number
    3006695864-2008-00027
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 30, 2008
    Manufacturer
    ADVANCE MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) PERFORMED A EXCIMER AND WAVESCAN EVALUATION AND FOUND THAT BOTH SYSTEMS MET SPECIFICATIONS AND PERFORMED AS INTENDED. CUT PLASTIC WITH THE EXCIMER LASER AND EVALUATED. NO ISSUES WERE DETECTED WITH THE CUT. A CLINICAL DEVELOPMENT SPECIALIST (CDS) PROVIDED SURGERY SUPPORT IN 2008 AND FOUND THE PHYSICIAN'S SETTINGS ON THE WAVESCAN WAS SET AT 6MM FOR PUPIL CALCULATION AND NO DAILY CALIBRATIONS WERE PERFORMED SINCE FOUR MONTHS EARLIER, SINCE THE SWITCH BACK TO THE 3.67 SOFTWARE. A REVIEW OF THE SCANS SHOWED THAT SOME OF THE SCANS WITH SOME LID/LASH OBSTRUCTION WERE NOT IN GOOD FOCUS.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A BILATERAL LASIK SURGERY IN 2008. POSTOPERATIVELY, THE FOLLOWING MONTH DURING A FOLLOW UP VISIT, IT WAS NOTED THAT THE LEFT (OS) EYE HAD VISUAL ACUITY OF 20/80. PATIENT IS CURRENTLY HAVING HEADACHES. THE PATIENT'S PREOPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 RIGHT (OD) EYE AND 20/30 OS. PATIENT'S POSTOPERATIVE BCVA IS 20/30 OD AND 20/80 OS AS OF THE SAME DAY. ADDITIONAL INFO HAS BEEN REQUESTED. THE ASSOCIATION BETWEEN THE EVENT AND THE DEVICE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX WAVESCAN WAVEFRONT SYSTEM WAVEFRONT MEASUREMENT LZS ADVANCE MEDICAL OPTICS 0070-1006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other STAR EXCIMER